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Regulatory Matters - Volume 30, Issue

Early in my regulatory medical writing career, I wrote several protocols in the cardiology therapeutic area. I was introduced to the cardiac biomarkers troponin I and N-terminal prohormone brain natriuretic peptide (NTproBNP), which are indicators…

Medical decision making at the individual and population level: The increasing role of evidence - Volume 30, Issue

The major change in medical decision making over the last 50 years has been the realisation that treatment decisions would be improved if doctors’ existing knowledge was supplemented by evidence generated systematically through health services…

News from the EMA - Volume 30, Issue

Zynteglo is a one-time treatment for a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions. It is a gene therapy that uses a viral vector (or modified virus) to deliver a working gene into…

Advances in the CRISPR-Cas9 system and gene therapy - Volume 32, Issue

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to…

News from the EMA - Volume 30, Issue

February 26, 2021 – EMA has recommended granting a marketing authorisation in the European Union (EU) for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic…

Biotechnology - Volume 31, Issue

This is the first Medical Writing Biotechnology regular section. Biotechnology is a broad subject. It can be defined by the use of biological systems and living organisms in production processes. Biotechnology has been around for thousands of years.…

From the Editor - EMWA and Medical Writing: 12 months into the pandemic - Volume 30, Issue

What a year! A year of corona, crisis, and challenges. But also a year of innovations, break - throughs, and opportunities. I am one to focus on silver linings and here are some to think about. I am immensely proud of being part of an industry that…

Clinical study reports: A snapshot for aspiring medical writers - Volume 32, Issue

Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…

Diversity in clinical trials: It takes a village - Volume 32, Issue

Clinical trials are becoming more complex and the efforts to optimise drug development are rapidly evolving. This Q&A gives a short overview of the strategies Bristol Myers Squibb implements to incorporate diversity into the clinical trial…

ADHD: A true neurodevelopmental disorder? - Volume 21, Issue

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common childhood disorders. First described in 1798 by Alexander Crichton, ADHD became widely known outside the medical profession with the publication of the story of Fidgety Phil…

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Scope

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

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Chris Monk